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NCT Number: NCT06816836

Measuring Ultrasound Guided Skeletal Muscle Mass of Lower Extremity as a Predictor of Post-Operative Length of Stay in Exploratory Gynae-oncology Surgeries

Increased incidence of Gynae-oncological cancer is observed specifically in women above 50 years of age. Sarcopenia (a progressive and generalized loss of skeletal muscle mass, quality, and strength) is considered a reliable indicator of frailty, a poor prognostic factor in these patients. Various frailty scores and measurement of psoas muscle mass are time consuming, can't be done in patients unable to walk and altered mental status. The investigators wanted to evaluate if bedside ultrasound guided skeletal muscle measurement, as a measure of sarcopenia, can be used to predict post operative length of stay.

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Key information

Age range

50 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location status: Recruiting

Location contact

Amartya Chaudhuri, MD

SUB_INVESTIGATOR

Jaydip Bhaumik, MS

SUB_INVESTIGATOR

Priya Ghosh, MD

SUB_INVESTIGATOR

Rakhi Rakhi, MD

CONTACT

[email protected]

9051133005

Rakhi Rakhi, MD

PRINCIPAL_INVESTIGATOR

Shikhar More, DM

SUB_INVESTIGATOR

Subhashree Rout, MS

SUB_INVESTIGATOR

About this study

Gynae-oncological patients comprise a significant proportion of all new cancers and death related to cancer. Abrupt increase in the incidence of these cancer is observed specifically between women of 50-60 years of age. Therefore, it is important to evaluate the factors which influence postoperative outcomes in such patients. Sarcopenia, defined as a progressive and generalized loss of skeletal muscle mass, quality, and strength is considered a reliable indicator of frailty, a poor prognostic factor in cancer.

Usually, various frailty scores and measurement of psoas muscle mass with the abdominal pelvic CT scan are used as markers of sarcopenia. But these scores are time consuming, can't be done in patients unable to walk and altered mental status. Routine use of CT scan exposes the patient to radiation and may not be necessary.

The investigators wanted to evaluate if bedside ultrasound guided skeletal muscle measurement, as a measure of sarcopenia, can be used to predict adverse post operative outcomes in open gynae-oncology surgery in patients more than 50 years of age.

This will be a prospective observational cohort study. Total 320 patients will be recruited considering 1:1 ratio of sarcopenia vs non sarcopenia patients above the age of 50 years undergoing open gynae- oncology surgery.

The investigators will be collecting all relevant data other than skeletal muscle mass measurement (psoas major, rectus femoris, vastus intermedius and tibialis anterior) that can contribute to adverse post operative outcomes. In the preoperative period Charlson's comorbidity index, Serum albumin, creatinine and blood haemoglobin value, preoperative Functional status by 6-minute walk test, existing frailty by using Fried phenotype score and if patient has received neoadjuvant chemotherapy will be noted. Intraoperatively duration of surgery, Surgical complexity score, blood loss will be collected. In the post operative period,- length of hospital stay, Clavien Dindo score, Post operative morbidity score, 30 and 90 days readmission and 30 and 90 day mortality after discharge will be noted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All consecutive consenting patients above 50 years of age, having a Charlson Comorbidity Index score of 3 or more, undergoing open surgeries for GCs.

Exclusion criteria

A. Refusal of consent B. Patients with psychiatric illnesses who are unable to follow instructions. C. Patients below the age of 50 years. D. Patients with known neuromuscular disorders. E. Patients in whom contrast-enhanced CT scan of the abdomen and pelvis is not done.

F. Previous major surgery of limbs (Amputation, Hip surgeries/ long bone surgeries)

Treatment and study plan

Bed Side ultrasound guided muscle mass estimation of lower extremity

Procedure

Bed Side ultrasound guided muscle mass estimation of psoas major, rectus femoris, vastus intermedius and tibialis anterior.

Other names: Preoperative Charlson's comorbidity index scoring, Frailty by using Fried phenotype score, Markers of Sarcopenia from Abdominal pelvic CT scan

Primary outcomes

  1. Prolonged length of hospital stay

    Time frame: 3 Years

    Length of hospital stay above 3rd Quartile at 9 days

Secondary outcomes

  1. Incidence of severe morbidity as classified by the Clavien Dindo Score.

    Time frame: 3 years

    Incidence of severe morbidity as classified by the Clavien Dindo Score.

  2. Type of morbidity as defined by the Post Operative Morbidity Survey.

    Time frame: 3 years

    Type of morbidity as defined by the Post Operative Morbidity Survey.

  3. 30-day and 90-day readmission

    Time frame: 3 years

    Readmission within 30 day/ 90 days from the day of discharge

  4. 30-day and 90-day mortality.

    Time frame: 3 years

    Mortality within 30 day/ 90 days from the day of discharge

Sponsors and collaborators

Lead sponsor

Tata Medical Center

Other

Registry information

Acronym: MUSLES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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